Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Institut Gustave Roussy.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Institut Gustave Roussy

ClinicalTrials.gov Identifier:

NCT00935675

First received: July 7, 2009

Last updated: September 1, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2009
Last Updated Date	September 1, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 8, 2009)	Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months [ Time Frame: 3 months ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00935675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
Official Title ^ICMJE	Not Provided
Brief Summary	Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Carcinomas
Intervention ^ICMJE	Drug: Escitalopram Escitalopram 10 mg once a day
Study Arm (s)	Active Comparator: Antidepressant treatment Intervention: Drug: Escitalopram Placebo Comparator: Placebo Intervention: Drug: Escitalopram
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Head and neck squamous cell carcinomas, stage I to IVb First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy HADS- T >11 Aged 18 to 75 yo, written consent required OMS>2 Exclusion Criteria: Palliative care Previous head and neck cancer Bipolar disorder or schizophrenia Severe major depressive disorder (DSM-IV TR) Expressed suicidal ideation Severe untreated organic disorder, especially acute infectious disorder ASAT/ALAT > 3N Clearance of creatinin < 30 ml/mn Hyponatremia Antecedent of delirium tremens or acute alcohol withdrawal disorder Antecedent of upper gastro-intestinal bleeding Antecedent of toxicity or inefficacy of a previous treatment with escitalopram Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline Pregnancy or lactation
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00935675
Other Study ID Numbers ^ICMJE	TADDOR, CSET 1388
Has Data Monitoring Committee	Not Provided
Responsible Party	SARAH DAUCHY MD
Study Sponsor ^ICMJE	Institut Gustave Roussy
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Institut Gustave Roussy
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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